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This is a Phase I/IIa, open-label, multi-center, dose-escalation, and expansion study to evaluate the safety, tolerability, PK and preliminary anti-tumor activity of ASN-3186 when given orally in subjects with advanced solid tumors
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental | Participants will receive ASN-3186 in sequential cohorts of increasing doses. |
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| Dose Expansion | Experimental | Recommended doses from dose escalation stage will be studied to determine RP2D. |
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| Tumor-specific Cohort Expansion | Experimental | RP2D will be further studied in tumor-specific cohorts. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASN-3186 | Drug | ASN-3186 will be administered orally. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| phase 1( Dose Escalation Stage): Dose Limiting Toxicity (DLT) | DLT will be defined as toxicities that meet pre-defined severity criteria(according to the NCI CTCAE v5.0 toxicity assessment criteria), | During the first 26 Days |
| phase 1( Dose Escalation Stage): Recommended phase 2 dose(RP2D) | RP2D is recommended based on MTD, safety data , efficacy data, and clinical pharmacokinetic (PK) characteristics | 14 months |
| phase 2a: ORR | ORR assessed by investigators. | 26 months |
| Measure | Description | Time Frame |
|---|---|---|
| phase1:PK characteristics | Plasma PK characteristics and metabolite PK characteristics of ASN-3186 after single or multiple oral administration | 14 months |
| phase1: QT/QTc | To evaluate the effect of ASN-3186 on QT/QTc interval in patients with advanced solid tumors |
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Key Inclusion Criteria:
Key Exclusion Criteria:
1. Treatment with any of the following:
2.Subjects who expect to require any other form of anti-tumor therapy during the treatment period. 3. Subjects who have unresolved toxicity greater than common terminology CTCAE V5.0 Grade 1 from prior anti-tumor therapy prior to the first dose of ASN-3186, except for alopecia and chemotherapy-induced peripheral neurotoxicity ≤ CTCAE V5.0 Grade 2. 4. Subjects who have undergone surgery on vital organs (other than aspiration biopsy) or suffered major trauma within 4 weeks prior to the first dose, or subjects who have not recovered from any surgical effect at screening, or subjects who are scheduled for major surgery during the study period. 5. Subjects who have gastrointestinal disorders that will affect oral administration or affect the absorption of ASN-3186 as judged by the investigator. Or subjects who have severe or clinically significant gastrointestinal disease (e.g., refractory diarrhea, intractable vomiting, colitis, etc.) within 4 weeks prior to the first dose of ASN-3186 and did not recover to CTCAE V5.0 Grade 1.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zijia Wang | Contact | +86-021-68583863 | zjwang@asieris.cn |
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| ASN-3186 |
| Drug |
ASN-3186 will be administered orally. |
|
| ASN-3186 | Drug | ASN-3186 will be administered orally. |
|
| 14 months |
| phase1: ECG | To evaluate other electrocardiogram(ECG) parameters of ASN-3186 in patients with advanced solid tumors | 14 months |
| phase1+2a:AE | The occurrence of all adverse events (AE). | 28 days after the last administration |
| phase1+2a:Serious adverse events (SAE) | The occurrence of all serious adverse events (SAE) | 28 days after the last administration |
| phase1+2a: Disease Control Rate(DCR) | Disease Control Rate defined as the rate of CR+PR+SD | 14months |
| phase1+2a: DOR | duration of response(DoR):The time during study treatment from the first tumor assessment of CR or PR to the first assessment of disease progression or all-cause death | 14 months |
| phase1+2a: CBR | clinical benefit rate (CBR): Proportion of patients whose best response was observed to be CR, PR, or SD (duration ≥24 weeks) over the study period | 14 months |
| phase1+2a: PFS | progression-free survival(PFS): From the date of first study treatment to the time of disease progression or all-cause death | 14 months |
| phase1+2a: OS | overall survival(OS):From the date of first study treatment to the time of all-cause death | 14 months |
| phase1+2a: biomarker | Relationship between biomarker and efficacy | 14 months |